Pharmacy Laws & Regulations - Chapter 2

5 Written Questions

1. Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.
2. A record maintained by the nursing staff containing information about the patients medication and it's frequency of administration.
3. a federal insurance program for persons over the age of 65 and qualified disabled or blind persons regardless of income
4. This law was passed by congress because of the concern about the risks to public health and safety associated with unsanitary and poorly labeled foods and drugs.
5. Omnibus Budget Reconciliation Act of 1990. Mandated three main provisions. Drug manufacturers provide the lowest price to medicaid patients. That drug review and patient counseling are now mandated.

5 Matching Questions

1. Medicare part D
2. State board of pharmacy.
3. Food and drug Administration modernization Act of 1997. (FDAMA)
4. Kefauver-Harris Amendment
5. Drug Enforcement Agency

1. a Body established to ensure that the public is well served professionally by pharmacist.
2. b Used to help manufacturers to quickly get their drugs to market. Encourage manufacturers to conduct research for new uses of drugs and to submit new drug applications. (NDAs). To encourage drug manufacturers to perform pediatric studies of drugs.
3. c A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act(CSA). To combat controlled substance abuse.
4. d An amendment to the federal food and cosmetic act that required all new drugs marketed in the united states to be shown to not only safe, but effective.
5. e A voluntary prescription drug benefit to medicare.

5 Multiple Choice Questions

1. A declaration ensuring that all patients, inpatients, outpatients, and emergency patients are afforded their rights in a health care institution.
   1. The Orange Book
   2. State board of pharmacy.
   3. The patients Bill of Rights
   4. The Joint Commission
2. Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.
   1. NDC
   2. PPI
   3. PHI
   4. OSHA
3. Recognized standards that are similar to laws.
   1. Medicare part D
   2. Orphan Drugs
   3. quasi-legal standards
   4. Federal Statuates
4. Are used to treat relatively rare diseases. A rare disease is one that effects less then 200,000 persons or that the cost of developing it could not be made back from sales of the drug.
   1. OSHA
   2. Orphan Drugs
   3. PHI
   4. OBRA
5. Federal law through which the Food and Drug Administration promulgates it's rules and regulations (FDCA)
   1. Food Drug and Cosmetic Act
   2. Food and Drug Administration
   3. Drug Enforcement Agency
   4. Food, Drug, and Cosmetic Act of 1938.

5 True/False Questions

1. Federal versus state drug control laws. → Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.

   True        False

2. OSHA → Occupational Safety and Health Administration (1970). Was created to decrease hazards in the work place.

   True        False

3. HIPAA → Omnibus Budget Reconciliation Act of 1990. Mandated three main provisions. Drug manufacturers provide the lowest price to medicaid patients. That drug review and patient counseling are now mandated.

   True        False

4. PPI → Protected Health Information. Individually identifiable health information transmitted or maintained in any form. except employment records.

   True        False

5. Food and Drug Administration → Promulgates rules and regulation and standards; inspects drug and food facilities to ensure public safety regarding drug products.

   True        False